Senior Quality Engineer

Summary

The Senior Quality Engineer, IVD Quality supports the development, implementation, and maintenance of product-development QMS processes for GeneDx’s IVD and software-enabled IVD products, including design controls, risk management, design transfer, and related lifecycle processes. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team.

Serving as the Quality representative on assigned product core teams, the Senior Quality Engineer provides Quality review, guidance, and process support to ensure that cross-functional activities and supporting technical documentation meet established QMS, regulatory, and standards requirements.

Job Responsibilities

• Execute assigned IVD QMS and product-development activities, ensuring that lifecycle processes are operationalized and maintained in compliance with established standards.

• Draft, revise, route for review and approval, and maintain SOPs, work instructions, forms, templates, and other controlled quality-system documentation.

• Serve as the Quality representative on assigned product core teams and cross-functional working groups; provide practical Quality input, identify quality-system gaps, and escalate significant Quality, compliance, product-safety, and risk-based issues to the Director, IVD Regulatory and Quality, as appropriate.

• Support implementation and execution of design-control processes, including design plans, design inputs and outputs, design reviews, traceability, verification and validation documentation, design transfer documentation, and design-history-file records.

• Facilitate and review risk-management activities and documentation, including risk-management plans, risk assessments, risk controls, residual-risk documentation, and traceability to verification and validation activities.

• Support change-control, nonconformance, deviation, CAPA, complaint-handling, and post-market quality processes, including investigation documentation, root-cause analysis, action tracking, effectiveness checks, and trend reporting.

• Support internal audits, external audits, and inspection readiness for assigned areas by preparing objective evidence, participating in audits, tracking corrective actions, and assisting with responses to observations or requests.

• Compile and analyze assigned Quality metrics and prepare inputs for Quality-governance and management-review activities.

• Identify process gaps, compliance risks, and improvement opportunities; recommend and help implement practical, risk-based solutions.

• Support supplier-quality activities as assigned, including supplier documentation, design-transfer readiness, supplier change assessments, and supplier corrective-action follow-up.
• Promote a culture of quality, accountability, continuous improvement, and cross-functional collaboration.

Education, Experience, and Skills

• A bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology).
• Minimum of 6 years of Quality Engineering or Quality Assurance experience, with at least 4 years specifically within an IVD, molecular diagnostics, or medical device regulated environment.
• Practical experience applying quality-system and product-development requirements in a regulated environment, including FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as applicable.
• Expertise in technical writing and QMS development; demonstrated experience drafting, revising, and implementing Standard Operating Procedures (SOPs), work instructions, and quality templates.
• Strong understanding of the product development lifecycle, with experience serving on cross-functional core teams to ensure design history files and technical justifications are compliant and audit-ready.
• Experience using Ketryx or similar connected lifecycle management and automated compliance tools for traceability and lifecycle management is a plus.
• Experience supporting regulatory submissions and audits/inspections.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Certificates, Licenses, Registrations

• ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred.

Work Environment

• This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.

• Standard work hours are Monday through Friday, 9 AM to 5 PM EST.

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Pay Transparency, Budgeted Range

$131,037

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$145,147 USD